Statistical Associate Job Description
Statistical Associate Duties & Responsibilities
To write an effective statistical associate job description, begin by listing detailed duties, responsibilities and expectations. We have included statistical associate job description templates that you can modify and use.
Sample responsibilities for this position include:
Statistical Associate Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Statistical Associate
List any licenses or certifications required by the position: SAS, FRM
Education for Statistical Associate
Typically a job would require a certain level of education.
Employers hiring for the statistical associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Statistics, Computer Science, Mathematics, Biostatistics, Science, Education, Life Science, Biological Sciences, Technical, Computing
Skills for Statistical Associate
Desired skills for statistical associate include:
Desired experience for statistical associate includes:
Statistical Associate Examples
Statistical Associate Job Description
- Ability to work effectively in a matrix organization and prioritize in a deadline oriented environment
- Projects will be open ended with time and resource constraints
- Proficient/Expert user of Microsoft Excel / Access / Word
- The individual is responsible for the performance management, development salary administration for direct reports, staff recruitment and will make decisions appropriate to this type of oversight and management
- Actively participate or lead Community of Practice, operational strategy and process recommendations
- Provides supervisory support to direct reports, including coaching, mentoring, training, career development, priority setting
- Provides strategic input into departmental staffing and/or sourcing strategy and ongoing evaluation of staffing/sourcing model
- Ensures compliance with department SOPs, policies and regulatory guidance documents
- Coordinates with other OFLs, Value Stream Leads and colleagues to ensure alignment of departmental roles and responsibilities
- Fulfils role of business owner for processes of medium/high complexity and/or significant departmental or cross-functional impact
- Other relevant Majors
- Leads departmental projects and implements solutions in collaboration with others
- Provides leadership in establishing operational strategy and process recommendations
- Ensures quality and compliance is monitored for deliverables, may provide input into the establishment of metrics
- Takes a leadership role in process improvement initiatives as appropriate
- Fulfils the role of a SPOC for external sourcing providers being responsible for establishing a strategic partnership, ensuring adherence to contract agreements, following up on capacity management, deliverables and compliance in close collaboration with other IDAR partners and procurement
Statistical Associate Job Description
- Responsible for completing quality assurance and validation procedures on assigned SAS programs
- Responsible for coordinating all programming activities for assigned projects
- Responsible for developing SAS applications using higher level SAS features
- Responsible for development of the SAS clinical study databases
- Ensures proper execution and validation of all statistical programs within a project according to specifications
- Develops and maintains timelines of statistical programming activities for the projects assigned by meeting with biostatisticians, other statistical programmers, data management, clinical, and medical personnel to determine workload and completion times
- Participates in the development of the TLG shells and DDR with biostatisticians
- Provides electronic data interchange support with other departments, outside contractors, international affiliates and regulatory agencies as requested
- Codes, tests and documents the development of SAS programs that generate output in conformance with defined specifications of tables/listings/graphs and other programs as assigned by manager
- Creates study databases following the study database specifications as directed
- In-depth knowledge of project management and leading teams is required
- Knowledge related to talent development and relevant personnel policies and procedures is preferred
- Knowledge of cross-functional working environment and industry trends that have an effect on departmental resources is required
- Performs quality assurance checks and validation of SAS programs and prepares documentation of results
- Develops, modifies, test, validates, and documents SAS Macro procedures for standardized tables and graphical summaries
- Reviews statistical analysis plan components (e.g., TLG shells)
Statistical Associate Job Description
- The incumbent is responsible for implementing departmental objectives and managing resource and operational challenges
- The position ensures appropriate and consistent application of SOPs, standards and quality and compliance measures
- Provides technical and/or scientific guidance to employees and colleagues
- Contributes to building and fostering group capability for the delivery of expertise, and behaviors required to deliver success on projects
- Position is responsible for hiring appropriate, qualified staff
- Oversee the development and implementation of programming SOPs and work instructions, including programming validation and documentation
- Provide programming leadership and guidance as a member of the Biostatistics and Programming Leadership Team for preparation of submission-readiness datasets
- Develop and maintain programming infrastructure standards to support CSR, ad hoc analysis, publications, DSUR
- Lead and work collaboratively with business stakeholders such as Clinical Science, Clinical Operation, Data Management, Biostatistics, Drug Safety, regulatory, and Medical Writing to maximize automation processes for data extraction, coding, reconciliation, and periodic data review listings/patient profiles to expedite clinical data review if applicable
- Ensure the filing of study documentation is maintained to the standard required according to processes and is acceptable for audit
- BA/BS in Statistics or Biostatistics or equivalent with typically 7+ years relevant experience or typically 5+ years' experience with a Master's degree or 2+ years' experience with a Ph.D
- At least 7+ years' experience in a programming role preferably supporting clinical trials/ or in the pharmaceutical industry (5+ years for MS Statistics/Computer Science graduates Expert knowledge of/experience with SAS software)
- Good understanding of global clinical trials practices, procedures, methodologies
- Good understanding of regulatory requirements relevant to SR
- Experience in providing recommendations for maintenance or development of SR global policies, procedures and clinical data presentation standards
- Experience managing a team of statistical programmers in the development and execution of statistical analysis and reporting deliverables
Statistical Associate Job Description
- Develop SAS programs to generate TLGs according to the requirementsusing Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS
- Create CDISC SDTM and ADaM files, SAS export files, and define.xml for electronic submissions
- Draft and/or review data specifications for analysis datasets
- Review deliverables (e.g., TLGs for study reports, submission documents, publications, meeting presentations, and ad-hoc requests) for accurate and on-time delivery
- Review CRF design, data management plan, data validation plan, and edit check specifications
- Applyand promote good programming practices
- Contribute to development of standard macros
- Interact with statisticians and interdisciplinary teams on timelines and content of deliverables
- Manage day-to-day activities of statistical programming staff
- Participate in Human Resources activities of the department (staffing, performance management and employee development)
- Broad knowledge and demonstrated experience in developing analysis and reporting statistical programming deliverables using global and TA standards and according to quality, compliance and timeliness requirements
- Expertise in SAS and clinical trial programming including data steps and procedures
- Knowledge of regulatory agency requirements pertaining to statistical computing and programming issues
- Experience leading the activities of a programming team that includes outsource-partner, contractor, and global resources
- Experience contributing to project resource allocation and forecasting activities at the late-stage development portfolio level
- Bachelor or Master’s Degree in Statistics or related fields
Statistical Associate Job Description
- Participate in the analysis of data from large medical databases
- Participate in the analysis of translational research data potentially including high dimensional data
- Prepare written summaries and tables of results for use in study reports and scientific papers
- Perform (i) the programming, testing, and documentation of statistical programs for use in crafting statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients and (iii) the programming quality control checks for the source data and report the data issues periodically
- Detect errors in detail and corrects them (e.g., reviews tables/listings, edit checks output and SAS programs to ensure quality of deliverable)
- Assist in the development of programming documentation including specifications, as appropriate, under supervision
- Provide advanced technical expertise in conjunction with clients, and independently bring project solutions to Statistical Programming teams and department, for complex studies
- Develop, implement and validate new process technologies, macros and applications under supervision
- Fulfill project responsibilities at the level of assisting the statistical programming team lead
- Experience in Statistical programming in SAS within the CRO/Pharmaceutical/Biotechnology/Healthcare industries
- A B.S., M.S., or Ph.D
- Excellent working knowledge of Base SAS (including macro language, Proc SQL, and ODS), SAS/GRAPH,and SAS/STAT
- Good working knowledge of CDISC SDTM and ADaM models preferred
- Previous experience managing temporary, contract and regular employees
- Knowledge of and ability to adhere to GCP principlesand relevant regulatory requirements
- An aptitude for quantitative problem solving with the capacity to troubleshoot and work independently